Effect of Human Rotavirus Vaccine on Severe Diarrhea in African Infants

• Published in: Malawi medical journal Vol. 362; no. 4; pp. 289 - 298
• Main Authors: Madhi, Shabir A, Cunliffe, Nigel A, Steele, Duncan, Witte, Desirée, Kirsten, Mari, Louw, Cheryl, Ngwira, Bagrey, Victor, John C, Gillard, Paul H, Cheuvart, Brigitte B, Han, Htay H, Neuzil, Kathleen M
• Format: Journal Article
• Language: English
• Published: Waltham, MA Massachusetts Medical Society 28.01.2010
• Subjects: Age; Antibodies, Viral - blood; Biological and medical sciences; Children; Children & youth; Clinical trials; Clinics; Consent; Diarrhea; Diarrhea, Infantile - epidemiology; Diarrhea, Infantile - prevention & control; Feces - virology; Female; Gastroenteritis; Gastroenteritis - epidemiology; Gastroenteritis - prevention & control; Gastroenteritis - virology; General aspects; HIV; HIV Infections - diagnosis; Human immunodeficiency virus; Humans; Immunization; Incidence; Infant; Infants; Laboratories; Malawi - epidemiology; Male; Medical sciences; Rotavirus; Rotavirus - classification; Rotavirus - immunology; Rotavirus - isolation & purification; Rotavirus Infections - epidemiology; Rotavirus Infections - immunology; Rotavirus Infections - prevention & control; Rotavirus Vaccines - administration & dosage; Rotavirus Vaccines - adverse effects; Rotavirus Vaccines - immunology; South Africa - epidemiology; Surveillance; Teams; Vaccine efficacy; Vaccines; Vaccines, Attenuated - administration & dosage; Vaccines, Attenuated - adverse effects; Vaccines, Attenuated - immunology; Viruses; Malawi; South Africa; Africa; Human; Rotavirus; Human rotavirus; Vaccination; Diarrhea; Infant; Vaccine; Reoviridae; African; Virus; Medicine; Digestive diseases; Intestinal disease; Severe
• ISSN: 0028-4793; 1533-4406; 1995-7270
• DOI: 10.1056/NEJMoa0904797

Rotavirus is the leading cause of gastroenteritis in children worldwide. In this report, the efficacy of the rotavirus vaccine among 4417 children in Malawi and South Africa was studied in a randomized trial. Severe rotavirus gastroenteritis occurred in 4.9% of the infants in the placebo group as compared with 1.9% of the infants in the pooled vaccine group; the vaccine efficacy was 61.2%. In this trial of rotavirus vaccine in Malawi and South Africa, severe rotavirus gastroenteritis occurred in 4.9% of the infants in the placebo group as compared with 1.9% of the infants in the pooled vaccine group; the vaccine efficacy was 61.2%. Rotavirus is the most important cause of severe gastroenteritis among children worldwide. The World Health Organization (WHO) estimates that globally 527,000 deaths occur each year among children as a result of rotavirus infection 1 ; more than 230,000 of the deaths occur in sub-Saharan Africa. Six of the seven countries with the highest mortality due to rotavirus diarrhea are located in Africa. 2 Similarly, data generated from global rotavirus surveillance networks highlight the burden of hospitalizations for rotavirus 3 ; among young children hospitalized for acute diarrhea, the median detection rate for rotavirus was 40% globally and 41% in Africa. Therefore, measures to . . .